AccessGUDID - DEVICE: TSKgel G7 β-Thal. HSi (04560189283114)

GUDID

Device Identifier (DI) Information

Brand Name: TSKgel G7 β-Thal. HSi
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOSOH CORPORATION

Primary DI Number: 04560189283114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690571724 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55880	Haemoglobin A2 (HbA2) IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) in a clinical specimen using an electrophoresis method.	Active	false
55897	Haemoglobin F (HbF) IVD, kit, electrophoresis	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype F (HbF), also known as foetal haemoglobin, in a clinical specimen using an electrophoresis method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JPD	Hemoglobin A2 Quantitation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 15 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a18992cf-1788-4307-9ae9-fcb2c7337678
Public Version Date: April 01, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 614-317-1909
Email: Levent.durukan@tosoh.com

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